Colorectal Cancer Clinical Trial
Official title:
A Real World Study of Efficacy and Safety for Apatinib Treatment as the Neoadjuvant Therapy in Advanced Colorectal Cancer
Apatinib has been proved to be effective and safe among patients in advanced colorectal cancer in several trials. the investigators aimed to evaluate its efficacy and safety as the neoadjuvant therapy in real world practice, and to explore factors associated with efficacy.
Regorafenib (BAY 73-4506, commercial name Stivarga) is an oral multi-kinase inhibitor
developed by Bayer which shows anti-angiogenic activity due to its dual targeted VEGFR2-TIE2
tyrosine kinase inhibition.Regorafenib demonstrated to increase the overall survival of
patients with metastatic colorectal cancer and has been approved by the CFDA in 2017.
Apatinib, a small molecule receptor tyrosine kinase (RTK) inhibitor, targets the
intracellular domain of the VEGFR-2 ATP binding site, and is the first anti-angiogenic
therapy approved by the China Food and Drug Administration in December 2014 for the treatment
of metastatic gastric cancer in third-line or later treatment. It is an orally bioavailable,
small molecule agent which is thought to inhibit angiogenesis in cancer cells; specifically
apatinib inhibits VEGF-mediated endothelial cell migration and proliferation thus blocking
new blood vessel formation in tumor tissue. It is an investigational cancer drug currently
undergoing clinical trials as a potential targeted treatment for metastatic gastric
carcinoma, metastatic breast cancer ,advanced hepatocellular carcinoma and advanced
colorectal cancer.
Apatinib are often used in advanced colorectal cancer for uses that are not within its
approved indication for use.However, the knowledge gained from all uses of apatinib in this
medical practice is often not realized because the data collected are not systematically
characterized, aggregated, and analyzed in a way that can be relied upon to inform its
further usage.
In some cases, a "traditional" clinical trial may be impractical or excessively challenging
to conduct. Ethical issues regarding treatment assignment, and other similar challenges, may
present themsevels when developing and attempting to execute a high quality clinical trial.
Analyses of real-world data(RWD), using appropriate methods, may in some cases provide
similar information with comparable or even superior characteristics to information collected
and analyzed through a traditional clinical trial. For example, RWD collected using a
randomized exposure assignment within a registry can provide a sufficient number of patients
for powered subgroup analyses.
the investigators will evaluate the efficacy and safety for Apatinib combine with other
chemotherapy regimens as the neoadjuvant therapy in advanced colorectal cancer in a real
world study setting. This study leveraging RWD can potentially provide information on a wider
patient population, thus providing information that cannot be obtained through a traditional
clinical trial alone.
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